A Single Center Clinical Evaluation of Same Sitting Hybrid Revascularization: Robotic Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention for the Treatment of Coronary Artery Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/30/2019 |
| Start Date: | September 2008 |
| End Date: | December 2020 |
| Contact: | William Bachinsky, MD |
| Email: | wbachinsky@pinnaclehealth.org |
| Phone: | 7177310101 |
The primary objective of this study is to assess the safety and effectiveness of same
sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and
percutaneous coronary intervention (PCI) in the treatment of obstructive multivessel coronary
artery disease. A secondary objective is the assessment and standardization of optimal
operator techniques and comparative study of patients undergoing CABG during study period.
sitting, simultaneous hybrid robotic assisted coronary artery bypass grafting (CABG) and
percutaneous coronary intervention (PCI) in the treatment of obstructive multivessel coronary
artery disease. A secondary objective is the assessment and standardization of optimal
operator techniques and comparative study of patients undergoing CABG during study period.
The study population will consist of patients with multivessel coronary artery disease
requiring CABG with suitable anatomy for combination CABG and PCI of non-bypassed arteries.
The primary endpoint of this feasibility study is a 30-day composite of major adverse
clinical events including death, repeat revascularization, stroke and/or myocardial
infarction.
The secondary endpoints include:
1. Successful completion of same sitting CABG and coronary stent procedure
2. Successful completion of CABG and PCI during single hospitalization
3. Achievement of complete revascularization
4. Patency of the LIMA and stented vessels as determined by coronary angiography at time of
procedures or prior to discharge and by cardiac Computed Tomographic Angiography (CTA)
or coronary angiography at 1 year.
5. Stent thrombosis at 24 hours (acute), 30 days (sub acute), and 1 year (late)
6. One-year composite clinical event endpoints of major clinical events including death,
repeat revascularization, myocardial infarction, and freedom from angina
7. Comparative analysis of hospital, 30 day, and 1 year events of hybrid CABG patients
compared to consecutive patients undergoing off pump CABG with standard thoracotomy
during study period
requiring CABG with suitable anatomy for combination CABG and PCI of non-bypassed arteries.
The primary endpoint of this feasibility study is a 30-day composite of major adverse
clinical events including death, repeat revascularization, stroke and/or myocardial
infarction.
The secondary endpoints include:
1. Successful completion of same sitting CABG and coronary stent procedure
2. Successful completion of CABG and PCI during single hospitalization
3. Achievement of complete revascularization
4. Patency of the LIMA and stented vessels as determined by coronary angiography at time of
procedures or prior to discharge and by cardiac Computed Tomographic Angiography (CTA)
or coronary angiography at 1 year.
5. Stent thrombosis at 24 hours (acute), 30 days (sub acute), and 1 year (late)
6. One-year composite clinical event endpoints of major clinical events including death,
repeat revascularization, myocardial infarction, and freedom from angina
7. Comparative analysis of hospital, 30 day, and 1 year events of hybrid CABG patients
compared to consecutive patients undergoing off pump CABG with standard thoracotomy
during study period
Inclusion Criteria:
- Requirement for CABG
- Anatomy and body habitus suitable for Robotic CABG
- Requirement of revascularization of arteries amendable for PCI but not accessable by
Robotic CABG
Exclusion Criteria:
- Need for emergent CABG
We found this trial at
1
site
111 South Front Street
Harrisburg, Pennsylvania 17011
Harrisburg, Pennsylvania 17011
Principal Investigator: William Bachinsky, MD
Phone: 717-731-0101
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